Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients

NCT04552067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2020-09-17

No results posted yet for this study

Summary

Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended.

Demonstrate that Enoxa® is comparable to that of Lovenox® in the anti-Xa activity action.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Lovenox

patients given curative dose of Lovenox

DRUG

Enoxaparin

patients given curative dose of Enoxa

Sponsors & Collaborators

  • University Hospital Fattouma Bourguiba

    collaborator OTHER
  • University of Monastir

    lead OTHER

Principal Investigators

  • Nouira Semir, Professor · University hospital of Monastir

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-04-30
Completion
2014-01-31

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552067 on ClinicalTrials.gov